There has been a proliferation of analytical and diagnostic devices known as “point of care” devices. These devices are used professionally in clinics, doctors' offices, and hospitals, and are used by individual consumers for glucose, glycated hemoglobin, pregnancy and other tests. These devices are well known in the art and typically include a reagent pad in the form of a strip or built into a device for receiving a bodily fluid sample, and a meter or indicator device for giving the user a readout of the analysis results, such as glucose level, or a color indication of a condition present or not present, such as, pregnancy. In some cases the device is part of a test kit or system, which also includes a sample preparation portion, such as a sample dilution vial and solution.
Some of the point of care devices and kits have limited shelf life, including some devices and kits that are best kept under refrigeration, e.g., below about 10° C., in order to provide useful shelf life, particularly in the consumer or individual use market. For example, the METRIKA® A1c test kit (available from Metrika, Inc., Sunnyvale, Calif.) for glycated hemoglobin testing is recommended for storage under refrigeration in order to provide a one year shelf life. Without refrigeration, the Metrika A1c test kit is recommended for use within one month.
Thus, there is a need for improvement in point of care diagnostic devices and test kits to provide extended shelf life and in particular for extended shelf life without refrigeration.